- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02380768
A Comparison of the Ambu AuraGain Versus LMA Supreme in Children
17. juli 2015 oppdatert av: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children
The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme.
Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.
Studietype
Intervensjonell
Registrering (Faktiske)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
3 måneder til 6 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Scheduled for surgery utilizing a supraglottic airway device
- ASA (American Society of Anesthesiologists) I-III classification
- Weighing between 5 - 20 kilograms
Exclusion Criteria:
- Active respiratory infection
- History of difficult mask ventilation
- Diagnosis of congenital syndrome with difficult airway management
- Active gastrointestinal reflux
- Coagulopathy
- Significant Pulmonary disease
- Emergent surgery
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Ambu AuraGain
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
|
The device will be inserted and timed.
A leak pressure test will be performed after successful insertion and after 10 minutes.
The larynx will be visualized by placing a fiberoptic bronchoscope through the device.
A gastric tube will be inserted through the device and timed.
Andre navn:
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Aktiv komparator: LMA Supreme
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
|
The device will be inserted and timed.
A leak pressure test will be performed after successful insertion and after 10 minutes.
The larynx will be visualized by placing a fiberoptic bronchoscope through the device.
A gastric tube will be inserted through the device and timed.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Oropharyngeal (airway) leak pressure - Initial
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway
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Assessed intraoperatively at the time of confirmed device placement
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Oropharyngeal (airway) leak pressure - 10 Minutes
Tidsramme: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
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The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway
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Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time for Successful Placement of the Supraglottic Airway
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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Time for successful placement of supraglottic device will be recorded
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Assessed intraoperatively at the time of confirmed device placement
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Number of attempts to placement of Supraglottic Airway
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)
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Assessed intraoperatively at the time of confirmed device placement
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Fiberoptic Grade of Laryngeal View through Supraglottic Airway
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system
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Assessed intraoperatively at the time of confirmed device placement
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Gastric Tube Insertion Ease of Placement
Tidsramme: Assessed intraoperatively at the time of confirmed gastric tube placement
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The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.
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Assessed intraoperatively at the time of confirmed gastric tube placement
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Gastric Tube Insertion Time
Tidsramme: Assessed intraoperatively at the time of confirmed gastric tube placement
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The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded.
Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
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Assessed intraoperatively at the time of confirmed gastric tube placement
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Gastric Tube Insertion Attempts
Tidsramme: Assessed intraoperatively at the time of confirmed gastric tube placement
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Number of insertion attempts of the gastric tube through the SGA will be recorded.
Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
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Assessed intraoperatively at the time of confirmed gastric tube placement
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Postoperative Complications
Tidsramme: Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
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Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period.
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Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
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Intraoperative Complications
Tidsramme: Assessed intraoperatively
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Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur.
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Assessed intraoperatively
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Narasimhan Jagannathan, M.D., Ann & Robert H Lurie Children's Hospital of Chicago
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.
- Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.
- Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13.
- Jagannathan N, Sohn L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2015
Primær fullføring (Faktiske)
1. juni 2015
Studiet fullført (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først innsendt
26. februar 2015
Først innsendt som oppfylte QC-kriteriene
2. mars 2015
Først lagt ut (Anslag)
5. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. juli 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2015
Sist bekreftet
1. juli 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB 2015-252
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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